- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04893902
Digital VS. Conventional Ear Impression
An Innovative Approach for Auricular Rehabilitation Using Two Types Digital Impression Versus Conventional Techniques:
What is known:
Ear impressions are made in conventional manner by impression materials which may affect the accuracy of the obtained data and consume time and effort .
What this study adds:
Predesigned ear markers facilitate ear scanning using an intraoral scanner that decreases the probability of in-accuracies using the conventional manner with less time and effort
Study Overview
Status
Intervention / Treatment
Detailed Description
Prosthodontic maxillofacial rehabilitation of acquired or congenital ear defects is considered a challenging procedure. This clinical trial introduces a novel approach for digital scanning of the unaffected contralateral ear using an intraoral scanner in comparison to the conventional impression techniques. CAD/CAM is a very promising design and fabrication of an auricular prosthesis for patients with unilateral ear defects.
Purpose: This study aims to compare digital impression technique using an intra-oral digital scanner IOSfor the unaffected ear with markers /without markers versus traditional techniques with hydro colloidal impression materials.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed M dohiem, lecturer
- Phone Number: 01002411965
- Email: mdohiem@zu.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11742
- Recruiting
- Mohamed Mahmoud Dohiem
-
Contact:
- mohamed M DOHIEM, lecturer
- Phone Number: 00201002411965
- Email: mdohiem@zu.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- any normal patient
Exclusion criteria:
- no exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: conventional ear impression
|
ear scanning with intra oral scanner
|
|
Experimental: digital auricular impression without marker using intra oral scanner
|
ear scanning with intra oral scanner
|
|
Experimental: digital auricular impression with marker using intra oral scanner
|
ear scanning with intra oral scanner
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
total deviation between Conventional auricular impression and two types of digital impression
Time Frame: 1 day
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
total deviation between two types of digital impression
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- dohiem md
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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